Job Summary
The Senior Compliance Consultant position is responsible for independently managing compliance-related projects and providing consulting and contract services for quality-related issues. This position will be the subject matter lead for assigned areas and compliance projects within Quality Confidential.
Essential Duties
Responsible for independently managing compliance-related projects and providing Quality/GMP/Regulatory consulting and contract services to clients.
Develop, optimize, and/or manage client Quality Management Systems.
Author and/or review documents for cGMP compliance.
Keep pace with advances and technological changes in compliance services and the pharmaceutical/medical device/biotech industries.
Recognize and provide quality and regulatory support for deviations/non-conformances/CAPA.
Responsible for ensuring compliance of client operations to quality principles and GMP requirements.
Support the development of policies and procedures for all applicable business units within the company.
Ensure client compliance with all applicable internal and external policies procedures and industry best practices.
Utilize expertise of quality systems and GMP compliance to support the performance of audits, gap analyses, and risk assessments for clients.
Essential Duties and Minimum Requirement
Required: BS/BA in a scientific discipline.
Preferred: Graduate degree in a scientific discipline.
Minimum 15 years of quality management system experience.
Minimum 5 years managing quality operations, including GMP auditing, protocol, and batch review.
High attention to detail.
Strong working knowledge of ICH standards and international GMP regulations.
Ability to interact in a professional and positive manner with clients.
Strong editorial skills for the review and approval of GxP documentation, including protocols, reports, SOPs, etc.
Effective written and oral communication skills.
Ability to manage and execute multiple tasks within the compliance, quality assurance, and validation fields.
Ability to earn and maintain a client's confidence through appropriate planning, organizing, controlling, and directing of a project.
Ability to think ahead and prepare action plans to achieve results.
Excellent analytical skills and the ability to assess and resolve difficult business situations.
Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment.
About the Company
Quality Confidential engages the industry’s best talent to offer customized compliance solutions to clients in the pharmaceutical, biopharmaceutical, and medical device industries. We work with our specialized consultants to provide personalized project planning to ensure client project goals are met. Quality Confidential prioritizes partnering with consultants who are highly skilled, experienced, and passionate about problem-solving.
OUR CULTURAL BELIEFS
Authentic Communication - I speak up to create transparent, thoughtful, and timely dialogue.
Service Excellence - I value every client experience and its impact on results.
Passionate Work Ethic - I hold myself accountable and maintain high standards.
Integrity Over Profit - I act with our clients’ best interests in mind.
Creating Partnership from the Heart - I partner with anyone, anywhere to achieve results.